Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Cardiac Disease Clinical Trial

Official title:

Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707446
• Other study ID #: 11-0650-A
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: May 31, 2017
• Start date: January 2012
• Est. completion date: August 2016

Study information

• Verified date: May 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).

Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• age > 60 years

• combined valve and CABG

• repeat cardiac surgery

• multiple valve replacement or repair

• surgery of ascending aorta and aortic arch

• signed informed consent.

Exclusion Criteria:

• cardiac surgery without the use of cardiopulmonary bypass

• symptomatic cerebrovascular disease,

• history of delirium, or

• schizophrenia

Related Conditions & MeSH terms

• Cardiac Disease
• Delirium
• Heart Diseases

Intervention

Device:
• Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)
In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.

Other:
• An alarm threshold at 75% of the baseline rSO2 value
If the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.

Locations

Country	Name	City	State
Canada	University Heatlh Network, Toronto General Hopsital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who suffer from delirium postoperatively	Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.	Delirium we be assessed postoperatively for 7 days or Discharge